Isoniazid

Generic Name: Isoniazid

Brand Names: Isonarif, Isotamine, Isotamine B, Rifamate, Rifater

Drug Type: Small Molecule

Chemical Formula: C_₆H_₇N_₃O

CAS Number: 54-85-3

Unique Ingredient Identifier: V83O1VOZ8L

Background: Antibacterial agent used primarily as a tuberculostatic. It remains the treatment of choice for tuberculosis.

Indication: Isoniazid is used for the treatment of all forms of tuberculosis in which organisms are susceptible. It is also used in combination with rifampin and pyrazinamide.

Associated Conditions: Active Tuberculosis, Mycobacterium kansasii infection, Late phase Tuberculosis

Clinical Trials

PK Study of Anti-TB Drugs

Phase 1

Completed

Conditions: Tuberculosis

Interventions: Drug: Isoniazid (H)
Drug: Rifampicin (R)
Drug: Pyrazinamide (Z)
Drug: Ethambutol (E)

First Posted Date: 2015-05-29

Last Posted Date: 2018-10-03

Lead Sponsor: University of Oxford

Target Recruit Count: 61

Registration Number: NCT02457208

Locations: 🇹🇭
Shoklo Malaria Research Unit, Mae Sot, Tak, Thailand

An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis

Phase 2

Completed

Conditions: Tuberculosis
Multidrug Resistant Tuberculosis
Extensively-drug Resistant Tuberculosis

Interventions: Drug: Pyrazinamide
Drug: Linezolid
Drug: Ethionamide
Drug: Bedaquiline
Drug: Levofloxacin
Drug: Terizidone
Drug: Moxifloxacin
Drug: Kanamycin
Drug: Isoniazid

First Posted Date: 2015-05-27

Last Posted Date: 2021-09-29

Lead Sponsor: University of Cape Town

Target Recruit Count: 154

Registration Number: NCT02454205

Locations: 🇿🇦
Brooklyn Chest Hospital, Cape Town, Western Cape, South Africa

The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

Phase 3

Completed

Conditions: MDR-TB

Interventions: Drug: Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline)
Drug: Moxifloxacin
Drug: Clofazimine
Drug: Ethambutol
Drug: Pyrazinamide
Drug: Isoniazid
Drug: Prothionamide
Drug: Bedaquiline
Drug: Kanamycin
Drug: Levofloxacin

First Posted Date: 2015-04-06

Last Posted Date: 2023-09-28

Lead Sponsor: IUATLD, Inc

Target Recruit Count: 588

Registration Number: NCT02409290

Locations: 🇪🇹
Armauer Hanssen Research Institute, Addis Ababa, Ethiopia
🇪🇹
St. Peter's Tuberculosis Specializes Hospital, Addis Ababa, Ethiopia
🇬🇪
JSC National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia

and more 10 locations

Research on New Regimens for Retreatment Pulmonary Tuberculosis

Phase 4

Conditions: Reinfection Pulmonary Tuberculosis

Interventions: Drug: Isoniazid Aminosalicylate Tablets
Drug: Streptomycin injectable

First Posted Date: 2015-01-06

Last Posted Date: 2015-01-06

Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Target Recruit Count: 864

Registration Number: NCT02331823

Locations: 🇨🇳
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China

Assessing PA-824 for Tuberculosis (the APT Trial)

Phase 2

Completed

Conditions: Pulmonary Tuberculosis

Interventions: Drug: PA-824
Drug: Rifampin
Drug: Rifabutin
Drug: Pyrazinamide
Drug: Ethambutol
Drug: Isoniazid

First Posted Date: 2014-10-06

Last Posted Date: 2023-07-18

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 157

Registration Number: NCT02256696

Locations: 🇿🇦
University of Cape Town Lung Institute, Cape Town, South Africa

Brief Bactericidal Activity of Anti-Tuberculosis Drugs

Phase 1

Completed

Conditions: Tuberculosis
Drug-resistant Tuberculosis
Isoniazid Resistant Tuberculosis (Disorder)

Interventions: Drug: High dose isoniazid

First Posted Date: 2014-09-10

Last Posted Date: 2020-10-19

Lead Sponsor: Centers for Disease Control and Prevention

Target Recruit Count: 18

Registration Number: NCT02236078

Locations: 🇮🇳
National Institute for Research on Tuberculosis, Chennai, Tamil Nadu, India

Toward a Safe and Reachable Preventive Therapy for LTBI: a Multicenter Randomized Controlled Study in Taiwan

Phase 3

Conditions: Latent Tuberculosis Infection

Interventions: Drug: Rifapentine and Isoniazid for 3 months
Drug: Isoniazid for 9 months

First Posted Date: 2014-08-05

Last Posted Date: 2016-12-15

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 283

Registration Number: NCT02208427

Locations: 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan

NAT2 Genotyping in Re-challenge Protocol of INH Titration in Patients With Anti-TB Medications-induced Hepatitis

Not Applicable

Conditions: Hepatotoxicity

Interventions: Drug: isoniazid

First Posted Date: 2014-03-03

Last Posted Date: 2014-03-17

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 60

Registration Number: NCT02076685

Locations: 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan

A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers

Phase 1

Completed

Conditions: Tuberculosis

Interventions: Drug: Isoniazida

First Posted Date: 2014-01-23

Last Posted Date: 2014-01-23

Lead Sponsor: Oswaldo Cruz Foundation

Target Recruit Count: 28

Registration Number: NCT02043314

Locations: 🇧🇷
Synchrophar - Ass. e Desenv. de Projetos Clínicos Ltda., Campinas, São Paulo, Brazil

High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)

Phase 2

Completed

Conditions: Tuberculosis

Interventions: Drug: Isoniazid
Dietary Supplement: Vitamin B6

First Posted Date: 2013-09-06

Last Posted Date: 2023-02-17

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 282

Registration Number: NCT01936831

Locations: 🇭🇹
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (31730), Port Au Prince, Haiti
🇿🇦
TASK Applied Science CRS (31718), Bellville, South Africa

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